RE: RE: Reality January 19, 2012
CardioComm Solutions, Inc. Receives FDA Clearance to Market First
Over-the-Counter Heart Monitoring Solution
Firm Has Exclusive International Distribution of HeartCheck™ Pen &
Associated GEMS Home Software
Toronto, Canada - - January 19, 2012 - - CardioComm Solutions, Inc. (TSX-V: EKG), a global
medical provider of ECG acquisition and management software solutions, received clearance from
the Food and Drug Administration (FDA) for over-the-counter (OTC) sales and marketing of their
consumer-based, hand-held heart rhythm monitor known as the HeartCheck™ Pen Handheld ECG.
The FDA clearance also included CardioComm Solutions' GEMS™ (Global ECG Management
System) Home software, which enables the HeartCheck™ Pen to be connected to a personal
computer to upload the heart rhythm recording to CardioComm Solutions' C4 medical call service
telemedicine group for review by a physician.
The HeartCheck™ Pen and GEMS™ Home solution provide an extension to the HeartCheck™
ECG Monitor solution which may be used only under physician direction. Both devices can
communicate with CardioComm Solution's C4 medical call centre.
“Through this consumer product,” said Etienne Grima, CardioComm Solutions' CEO, “we are truly
putting people's heart health into their own hands.” The Pen will display only the heart rate count
until an interaction with a physician occurs. Once a C4 physician has provided review and feedback
to the customer, the Pen's screen can be unlocked to display the real-time ECG and heart rate
count for subsequent heart rhythm recordings.
“We feel the HeartCheck™ Pen is a true remote monitoring device because it is compact, easy to
use, and takes accurate heart readings in only 30 seconds. The Pen may be used from anywhere,
including at home, the office, the gym or in remote areas which are often inaccessible to common
ECG machines,” said Grima.
The HeartCheck™ Pen stores up to 20 ECGs, and its data can be downloaded to GEMS™ Home,
where repeated recordings can be managed in a personal health data record. The GEMS™ Home
software offers a simple software user interface for managing heart rhythm recordings and
associated data.
“What makes this product unique,” explained Grima, “is that after a consumer sends a selected
heart rate recording to the C4 medical call center over the internet using GEMS Home, the actual
ECG recording will be reviewed and interpreted by an attending C4 physician. The ECG report will
then be made available to the customer, again through GEMS™ Home, where they may retrieve
the ECG interpretation and use it in communicating with their own health care providers.”
“Any person interested in monitoring their health for primary or secondary disease reasons would
benefit from this solution,” stated Michael Baber, Business Development Director for the
HeartCheck™ brand. CardioComm Solutions is now in the process of developing market channels
for the distribution of this new device and service.
“Our cycle time for bringing this product to its current market-ready stage has been less than 14
months, and we intend to keep the momentum going,” reported Grima. Dr. Anatoly Langer,
Chairman of the Board for CardioComm Solutions confirms, “As a cardiologist, I believe this
development represents the cutting edge of the intersection between medicine and technology.
Informed consumers who wish to have the freedom and the security of monitoring their health will
welcome being connected when they wish to access the expertise that comes with our leading ECG
management software GEMS.”
“A priority for the current year is the global commercialization of the HeartCheck™ Pen Handheld
ECG Monitor and GEMS™ Home solution,” stated Grima. “In association with the launch of this
new offering, we are preparing for a financing round with an eye toward private placement.
Together with the anticipated completion of our new GEMS™ 4.0 platform, 2012 indeed promises
to be an exciting time for CardioComm Solutions.”
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More Information
For more information on the HeartCheck™ Pen or any CardioComm Solutions product or service,
call the sales and marketing group at 1-877-977-9425 toll free in the U.S. and Canada, or email
sales@cardiocommsolutions.com.
About CardioComm Solutions, Inc.
CardioComm's patented and proprietary technology is used in products for recording, viewing,
analyzing and storing electrocardiograms (ECGs) for diagnosis and management of cardiac
patients. Products are sold worldwide through a combination of an external distribution network and
a North Americanbased sales team. The company has earned the ISO 13485 certification, is HPB
approved, HIPAA compliant, and has received FDA market clearance for its software devices.
CardioComm Solutions, Inc. is headquartered in Toronto, Canada, with offices in Victoria, B.C.
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